Evaluation of a Marine OXYgen Carrier for Organ Preservation

  • STATUS
    Recruiting
  • End date
    Jan 24, 2023
  • participants needed
    460
  • sponsor
    University Hospital, Brest
Updated on 24 January 2021
Investigator
Yannick Lemeur, MD PhD
Primary Contact
Clermont-Ferrand (0.0 mi away) Contact
+21 other location

Summary

Preventing ischemia/reperfusion injuries (IRIs) is a major issue in kidney transplantation, particularly for transplant recipients receiving a kidney from extended criteria donors (ECD). The main consequence of IRIs is delayed graft function (DGF).

The medical device HEMO2life, an oxygen carrier developed by the Hemarina French Company, is a natural extracellular hemoglobin (Hb) isolated from the marine lugworm Arenicola marina. This biopolymer of high molecular weight (~3,600 kDa) has a large oxygen binding capacity, carrying up to 156 oxygen molecules when saturated (4 for human Hb). It releases oxygen according to a simple gradient and exhibits an intrinsic superoxide dismutase-like activity preventing both the occurrence of potentially harmful heme-protein-associated free radical species and the release of Hb degradation products.

Recently a safety study in 60 renal grafts using HEMO2life as additive to organ preservation solution (Oxyop study, NCT02652520) was completed, that confirmed that the use of HEMO2life is safe for patients and grafts.

In the Oxyop study, even if the protocol was not designed to show a benefit of the use of HEMO2life, significantly less delayed graft function (DGF) and a shorter renal function recovery was observed.

The present research focuses on the efficacy of HEMO2life, which is an oxygen carrier added in preservation solution in kidney transplantation.

Details
Condition End Stage Renal Diseases
Treatment Kidney Transplant
Clinical Study IdentifierNCT04181710
SponsorUniversity Hospital, Brest
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For Kidney graft
Any pair of kidneys retrieved in an adult donor in one of first line participating centers
Any pair of kidneys from a deceased donor after brain or cardiac death
For Patient
Male or female renal allograft recipients at least 18 years old
Patient who signed an inform consent form
Patient receiving one graft from an included pair of kidneys

Exclusion Criteria

For kidney
Graft from a living donor
Graft dedicated to a multi-organ transplantation or dual kidney transplantation
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